Afinitor Approval Expanded to Include Benign Kidney Tumors

FRIDAY April 27, 2012 -- Afinitor (everolimus) is the first drug to be approved by the U.S. Food and Drug Administration to treat benign kidney tumors among people with a rare genetic condition called tuberous sclerosis complex (TSC), the agency said in a news release.

TSC causes non-cancerous tumors of the brain, kidney and other organs, the FDA said. The disease affects up to 40,000 people in the United States, and as many as 80 percent develop kidney problems.

Afinitor helps suppress these tumors by blocking a protein that's essential for their development and growth, the FDA said.

The drug's safety and effectiveness were clinically evaluated among 118 people with TSC. The most common side effects were inflamed or sore mouth, nausea and vomiting, acne, eczema, cough, headache, diarrhea, abdominal pain, joint pain and swelling of the legs or arms. Some 15 percent of females who took Afinitor missed at least one menstrual period.

Afinitor was first approved by the FDA in 2009 to treat kidney tumors that weren't treated successfully with other drugs.